Quality Systems Manager

Birth Tissue Donor Services (BTDS) strives to be the preferred-choice partner for birth tissue donation and to provide exceptional service to our hospitals, physicians, and expectant parents. We honor a mother’s decision to donate in support of the need for transplantable human tissue. The generosity of these donors enables breakthrough medical applications that can restore vision and heal burns or wounds.

The Quality Systems Manager works under the direction of the Quality Systems Director. This role is responsible for overseeing organizational compliance and ongoing education/training to ensure the organization adheres to applicable federal, state, and local regulatory requirements and AATB Standards.

Primary Responsibilities:

· Knowledge and Compliance: Demonstrates comprehensive knowledge of BTDS’ standard operating procedures and policies. Understands and applies applicable regulated standards: American Association of Tissue Banks (AATB) and the Food and Drug Administration (FDA).

· Confidentiality: Maintains confidentiality of donor information at all times as outlined in the BTDS Confidential Information Form.

· Quality Management Systems: Oversees the maintenance of the Quality Manual, Policies, Procedures, and various management and monitoring tasks including:

· Internal and external audits

· Deviations and CAPAs

· Complaints

· Training and competency

· Equipment management and monitoring

· Facilities management and monitoring

· Material management and monitoring

· Record management and retention

· Document Control: Reviews and updates documents to ensure continuous improvement and compliance with FDA and AATB standards. Ensures timely review and update of master and archival files for procedure/form updates and document control.

· CAPAs: Facilitates and oversees Corrective and Preventive Actions (CAPAs) for deviations and complaints. Ensures CAPAs requiring additional education and/or training are completed with the assistance of Subject Matter Experts (SMEs) when required.

· Audits: Facilitates internal and external audits and oversees the development and implementation of CAPAs resulting from audits.

· Deviation and Complaint Management: Investigates, reviews, and follows up on all deviations, complaints, SCAR reporting, etc., until closure. Analyzes and identifies deviation trends and reports trends to the QS Director.

· Vendor/Supplier Qualification: Maintains, monitors, reviews, and completes vendor or supplier qualification as required per BTDS policy.

· Equipment Validation: Assists in the validation of new equipment and requalification of existing equipment as required. Monitors all equipment to ensure compliance with BTDS policies.

· Training: Tracks and maintains all employee training to ensure compliance. Facilitates training requirements with the assistance of SMEs as needed. Develops training for new Quality staff members.

· Additional Duties: Performs other duties as assigned, including but not limited to:

· Checking in tissue · Shipping tissue · Checking in supplies · Picking up ice · Greeting/receiving visitors in the front office

Education/Experience:

· High school diploma required

· Healthcare-related job experience preferred

· Minimum of 5 years’ experience in quality

· Obtain CTBS within 2 years

Physical/knowledge/skill and abilities description

· Knowledge of local, state and federal regulations pertaining to tissue bank operations.

· Demonstrate excellent written and verbal communication skills.

· Demonstrate excellent organization and customer relations skills

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Vision insurance

Application Question(s):

• Are you willing to undergo a background check AND provide three professional references?
• Do you have 5 years' experience in Quality?

Education:

• High school or equivalent (Required)

Ability to Relocate:

• Cookeville, TN 38501: Relocate before starting work (Required)

Work Location: In person